Senior Principal Statistical Programmer (Remote)

Nelson Mandela University; South Africa; Remote; ZAR 1,985,000 - 2,647,000; Full time

Benefits offered by this job

Equal Employment Opportunity

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely, embedded with a pharmaceutical sponsor. You will lead programming efforts across SDTM/ADaM, define.xml, and complex tables/graphs, while ensuring quality and regulatory compliance under FDA/ICH guidelines.

You will mentor junior staff and coordinate with CROs to meet study timelines. The role requires a senior programmer with 7+ years in biotech/pharma, strong SAS skills, CDISC expertise, and excellent

Qualifications

• Bachelor's degree in computer science, data science, mathematics or statistics (major preferred).
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma Clinical Development Biometrics.
• SAS programming skills with expertise in statistical programming procedures in a clinical development environment.

Responsibilities

• Generate SDTM, ADaM specs, datasets, reviewer's guides and Define.xml for multiple studies.
• Develop SAS programs to generate datasets, complex listings, tables and graphs.
• Deliver high-quality statistical programming results and validate SAS and/or R programs.
• Oversee CROs' statistical programming deliverables to ensure quality and timelines.
• Support preparation of clinical study reports, regulatory submissions, publications and DSURs.
• Follow FDA regulations and GCP for electronic submissions.

Skills

SAS programming

R

CDISC SDTM/ADaM

FDA/ICH regulations

Leadership

Communication

Independent work

Education

Bachelor's degree in Computer Science / Data Science / Mathematics / Statistics

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely, embedded with a pharmaceutical sponsor. You will lead programming efforts across SDTM/ADaM, define.xml, and complex tables/graphs, while ensuring quality and regulatory compliance under FDA/ICH guidelines.

You will mentor junior staff and coordinate with CROs to meet study timelines. The role requires a senior programmer with 7+ years in biotech/pharma, strong SAS skills, CDISC expertise, and excellent